Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-07

Study Completion Date

2017-09-30

Brief Summary

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A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia

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Detailed Description

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Conditions

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Hypertension Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test

qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin)

Group Type EXPERIMENTAL

Telmisartan + Amlodipine + Rosuvastatin

Intervention Type DRUG

Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo

Reference 1

qd PO, Micardis(telmisartan) + Crestor(rosuvastatin)

Group Type ACTIVE_COMPARATOR

Telmisartan + Rosuvastatin

Intervention Type DRUG

Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo

Reference 2

qd PO,Twynsta(telmisartan/amlodipine)

Group Type ACTIVE_COMPARATOR

Telmisartan + Amlodipine

Intervention Type DRUG

Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo

Interventions

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Telmisartan + Amlodipine + Rosuvastatin

Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo

Intervention Type DRUG

Telmisartan + Amlodipine

Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo

Intervention Type DRUG

Telmisartan + Rosuvastatin

Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults both male and female who are ≥19,\<80 years old
* at screening, 140mmHg≤ SBP\<180mmHg \& 90mmHg≤ DBP\<110mmHg \& LDL-C≤250mg/dL \& triglyceride\<400mg/dL

Exclusion Criteria

* at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg
* secondary hypertension or secondary dyslipidemia
* patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease
* women who are pregnant or lactating

Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No